Recall Z-1244-2025— Bard Peripheral Vascular Inc
Class I · Ongoing
Class I FDA medical device recall by Bard Peripheral Vascular Inc, initiated 2025-02-05. It names 3 FDA 510(k) clearances: K242757, K211738, K172315. Product: 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: 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..
- Recalling firm
- Bard Peripheral Vascular Inc
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2025-02-05
- Firm location
- Tempe, AZ, United States
510(k) clearances named in this recall
3 on FDA's record- K242757 — Rotarex Atherectomy System
- K211738 — Rotarex Atherectomy System
- K172315 — Straub Endovascular System
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.