Bard Peripheral Vascular Inc. is recalling 15,755 Rotarex Atherectomy Systems and their associated Instructions for Use because the internal rotating part of the catheter can break during medical procedures. The recall involves four models of the device (S 6 F and S 8 F sizes) distributed nationwide. The manufacturer has updated the Instructions for Use (IFU) to clarify specific procedural steps meant to prevent these breakage events.
The internal rotating helix of the catheter can fracture or break during use, which may require a surgical procedure to retrieve the fragments. If the device breaks, it can cause severe injury to blood vessels and lead to life-threatening bleeding.
Correction of Instructions for Use and replacement/return of affected devices.
Instructions for Use versions prior to ZE10895 revision C1 09/24.
Instructions for Use versions prior to ZE10895 revision C1 09/24.
Instructions for Use versions prior to ZE10895 revision C1 09/24.
Instructions for Use versions prior to ZE10895 revision C1 09/24.
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.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · FDA Press Release · Raw API Response
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