Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 80238; S 8 F x 110 cm, REF: 80239
Reported: March 12, 2025 Initiated: February 5, 2025 #Z-1244-2025
Product Description
Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 80238; S 8 F x 110 cm, REF: 80239
Reason for Recall
Atherectomy Catheter eIFU updated to clarify and emphasize procedural steps intended to reduce the likelihood of catheter breakage events. Catheter has an outer cylinder connected to a rotating helix, which could fracture and/or break, which would require retrieval, and helix facture/break could cause vessel injury and lead to severe bleeding.
Details
- Recalling Firm
- Bard Peripheral Vascular Inc
- Units Affected
- 15,755
- Distribution
- US Nationwide Distribution: NY, VA, KY, IN, OR, FL, MD, NJ, LA, CO, PR, PA, MS, MI, TX, KS, IL, CA, GA, OH, AL, NC, ND, AZ, SC, TN, UT, AR, WI, SD, MA, MO, ME, DE, WV , NV, NH, MN, CT, NE, IA, NM, WA, HI, and OK
- Location
- Tempe, AZ
Frequently Asked Questions
What product was recalled? ▼
Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 80238; S 8 F x 110 cm, REF: 80239. Recalled by Bard Peripheral Vascular Inc. Units affected: 15,755.
Why was this product recalled? ▼
Atherectomy Catheter eIFU updated to clarify and emphasize procedural steps intended to reduce the likelihood of catheter breakage events. Catheter has an outer cylinder connected to a rotating helix, which could fracture and/or break, which would require retrieval, and helix facture/break could cause vessel injury and lead to severe bleeding.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 12, 2025. Severity: Critical. Recall number: Z-1244-2025.
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