Angiodynamics, Inc.: Vascular Access Kits Recalled for Loose Metal Shavings and Embolism Risk

Agency Publication Date: May 3, 2024

Summary

Angiodynamics, Inc. is recalling approximately 2,518 units of various DuraFlow 2, DuraMax, and BioFlo DuraMax vascular access kits used for long-term hemodialysis. The Tri-Ball Tunneler components within these kits may contain loosely affixed metal shavings that could potentially enter a patient's bloodstream (embolize). This defect could lead to serious medical complications, potentially requiring invasive surgical procedures to remove the metal fragments.

Risk

If the loose metal shavings on the device enter the bloodstream during a procedure, they can travel to other parts of the body and block blood flow. This poses a risk of organ damage or other life-threatening complications that would require emergency surgery to resolve.

What You Should Do

Locate your medical device packaging and check the Product Number, UDI-DI, and Lot Number against the affected list to see if your kit is part of this recall.
For DuraFlow 2 24cm Straight Basic Kits (H787103012015), check for lot numbers 5807192 or 5807197.
For DuraMax Stacked Tip 24cm Basic Kits (H787103028035), check for lot numbers 5807194, 5809616, or 5809462.
For BioFlo DuraMax 15.5F 24cm Single Valve Sheath VascPak Kits (H965103038181), check for lot number 5810278.
If you identify an affected product in your inventory, stop using it immediately and quarantine the device to prevent further use.
Contact your healthcare provider or Angiodynamics, Inc. directly at 1-800-706-0129 to arrange for the return of affected products and to discuss potential medical concerns or refunds.
Healthcare professionals should monitor any patients who have recently undergone procedures with these devices for signs of embolism or internal injury.
For additional information, contact the FDA's medical device recall line at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer notification and device replacement/refund

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: DURAFLOW 2, 24CM STRAIGHT BASIC KIT

Model / REF:

H787103012015

UPC Codes:

25051684014738

Lot Numbers:

5807192

5807197

Product: DURAFLOW 2, 28CM STRAIGHT BASIC KIT

Model / REF:

H787103012021

UPC Codes:

15051684014748

Lot Numbers:

5805837

Product: DURAFLOW 2, 32CM STRAIGHT BASIC KIT PG

Model / REF:

H787103012035

UPC Codes:

25051684014752

Lot Numbers:

5805839

Product: DURAFLOW 2, 55CM STRAIGHT BASIC KIT PG

Model / REF:

H787103012115

UPC Codes:

15051684014786

Lot Numbers:

5805171

Product: DURAFLOW 2, 24CM STRAIGHT VASC-PAK PG

Model / REF:

H787103012185

UPC Codes:

25051684014820

Lot Numbers:

5805849

Product: DURAFLOW 2, 28CM STRAIGHT VASC-PAK PG

Model / REF:

H787103012195

UPC Codes:

25051684014837

Lot Numbers:

5807415

Product: DURAMAX STACKED TIP 24CM STR. BASIC KIT, 1-UP PG

Model / REF:

H787103028031

UPC Codes:

15051684011839

Lot Numbers:

5809463

Product: DURAMAX STACKED TIP 24CM STR. BASIC KIT, 5-UP PG

Model / REF:

H787103028035

UPC Codes:

25051684011836

Lot Numbers:

5807194

5809616

5809462

Product: DURAMAX STACKED TIP 28CM STR. BASIC KIT, 1-UP PG

Model / REF:

H787103028041

UPC Codes:

15051684011846

Lot Numbers:

5805840

Product: DURAMAX STACKED TIP 28CM STR. BASIC KIT, 5-UP PG

Model / REF:

H787103028045

UPC Codes:

25051684011843

Lot Numbers:

5807204

Product: DURAMAX STACKED TIP 32CM STR. BASIC KIT, 5-UP PG

Model / REF:

H787103028055

UPC Codes:

25051684011850

Lot Numbers:

5809646

Product: DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 1-UP PG

Model / REF:

H787103028191

UPC Codes:

25051684011850

Lot Numbers:

5807208

Product: DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 5-UP PG

Model / REF:

H787103028195

UPC Codes:

25051684011935

Lot Numbers:

5807195

5807196

Product: DURAMAX STACKED TIP 32 CM STRAIGHT VASC-PAK, 1-UP PG

Model / REF:

H787103028201

UPC Codes:

15051684011945

Lot Numbers:

5809464

Product: BioFlo DuraMax 15.5F 24cm Single Valve Sheath VascPak Kit

Model / REF:

H965103038181

UPC Codes:

25051684025680

Lot Numbers:

5810278

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94349

Status: Active

Manufacturer: Angiodynamics, Inc.

Sold By: Hospital supply networks; VA facilities

Manufactured In: United States

Units Affected: 15 products (455 units; 157 units; 35 units; 188 units; 83 units; 65 units; 50 units; 555 units; 30 units; 40 units; 260 units; 15 units; 285 units; 50 units; 250 units)

Distributed To: Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Locate your medical device packaging and check the Product Number, UDI-DI, and Lot Number against the affected list to see if your kit is part of this recall.

For DuraFlow 2 24cm Straight Basic Kits (H787103012015), check for lot numbers 5807192 or 5807197.

For DuraMax Stacked Tip 24cm Basic Kits (H787103028035), check for lot numbers 5807194, 5809616, or 5809462.

For BioFlo DuraMax 15.5F 24cm Single Valve Sheath VascPak Kits (H965103038181), check for lot number 5810278.

If you identify an affected product in your inventory, stop using it immediately and quarantine the device to prevent further use.

Contact your healthcare provider or Angiodynamics, Inc. directly at 1-800-706-0129 to arrange for the return of affected products and to discuss potential medical concerns or refunds.

Healthcare professionals should monitor any patients who have recently undergone procedures with these devices for signs of embolism or internal injury.

For additional information, contact the FDA's medical device recall line at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Affected Products

Product: DURAFLOW 2, 24CM STRAIGHT BASIC KIT

Model / REF:

H787103012015

UPC Codes:

25051684014738

Lot Numbers:

5807192

5807197

Product: DURAFLOW 2, 28CM STRAIGHT BASIC KIT

Model / REF:

H787103012021

UPC Codes:

15051684014748

Lot Numbers:

5805837

Product: DURAFLOW 2, 32CM STRAIGHT BASIC KIT PG

Model / REF:

H787103012035

UPC Codes:

25051684014752

Lot Numbers:

5805839

Product: DURAFLOW 2, 55CM STRAIGHT BASIC KIT PG

Model / REF:

H787103012115

UPC Codes:

15051684014786

Lot Numbers:

5805171

Product: DURAFLOW 2, 24CM STRAIGHT VASC-PAK PG

Model / REF:

H787103012185

UPC Codes:

25051684014820

Lot Numbers:

5805849

Product: DURAFLOW 2, 28CM STRAIGHT VASC-PAK PG

Model / REF:

H787103012195

UPC Codes:

25051684014837

Lot Numbers:

5807415

Product: DURAMAX STACKED TIP 24CM STR. BASIC KIT, 1-UP PG

Model / REF:

H787103028031

UPC Codes:

15051684011839

Lot Numbers:

5809463

Product: DURAMAX STACKED TIP 24CM STR. BASIC KIT, 5-UP PG

Model / REF:

H787103028035

UPC Codes:

25051684011836

Lot Numbers:

5807194

5809616

5809462

Product: DURAMAX STACKED TIP 28CM STR. BASIC KIT, 1-UP PG

Model / REF:

H787103028041

UPC Codes:

15051684011846

Lot Numbers:

5805840

Product: DURAMAX STACKED TIP 28CM STR. BASIC KIT, 5-UP PG

Model / REF:

H787103028045

UPC Codes:

25051684011843

Lot Numbers:

5807204

Product: DURAMAX STACKED TIP 32CM STR. BASIC KIT, 5-UP PG

Model / REF:

H787103028055

UPC Codes:

25051684011850

Lot Numbers:

5809646

Product: DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 1-UP PG

Model / REF:

H787103028191

UPC Codes:

25051684011850

Lot Numbers:

5807208

Product: DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 5-UP PG

Model / REF:

H787103028195

UPC Codes:

25051684011935

Lot Numbers:

5807195

5807196

Product: DURAMAX STACKED TIP 32 CM STRAIGHT VASC-PAK, 1-UP PG

Model / REF:

H787103028201

UPC Codes:

15051684011945

Lot Numbers:

5809464

Product: BioFlo DuraMax 15.5F 24cm Single Valve Sheath VascPak Kit

Model / REF:

H965103038181

UPC Codes:

25051684025680

Lot Numbers:

5810278

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94349

Status: Active

Manufacturer: Angiodynamics, Inc.

Sold By: Hospital supply networks; VA facilities

Manufactured In: United States

Units Affected: 15 products (455 units; 157 units; 35 units; 188 units; 83 units; 65 units; 50 units; 555 units; 30 units; 40 units; 260 units; 15 units; 285 units; 50 units; 250 units)

Distributed To: Virginia