| | Class 1 Device Recall Rotarex Atherectomy System |  |
| Date Initiated by Firm | February 05, 2025 |
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| Date Posted | March 05, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1244-2025 |
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| Recall Event ID |
96174 |
| 510(K)Number | K172315 K211738 K242757 |
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| Product Classification |
Catheter, peripheral, atherectomy - Product Code MCW
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| 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 |
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| Code Information |
Instructions for Use versions prior to ZE10895 revision C1 09/24.
REF/UDI-DI/Lot(Expiration):
80236/07640142811855/230893(2025-12-15), 231100(2026-06-09), 231172(2026-06-09), 231171(2026-06-09), 231526(2026-08-21), 231875(2026-08-21), 240018(2026-11-22), 240017(2026-11-22), 240375(2027-01-18), 240567(2027-01-18), 241075(2024-05-22), 241335(2024-06-19), 241550(2024-07-19), 241777(2024-08-19), 242691(2024-12-13);
80237/07640142811862/230897(2026-04-11), 230898(2026-04-11), 231033(2026-05-31), 231101(2026-06-13), 231170(2026-06-13), 231229(2026-07-07), 231400(2026-07-14), 231414(2026-07-31), 231412(2026-06-30), 231413(2026-07-31), 231411(2026-08-03), 231521(2026-09-01), 231520(2026-07-31), 231522(2026-08-31), 231523(2026-09-01), 231524(2026-09-01), 231525(2026-09-01), 231715(2026-09-22), 231885(2026-09-22), 231884(2026-10-27), 240020(2026-11-22), 240396(2026-12-08), 240530(2027-01-10), 240531(2027-01-10), 240566(2027-01-10), 240568(2027-01-25), 240754(2027-02-06), 240769(2027-02-09), 240795(2027-03-04), 241074(2027-03-07), 241119(2027-03-21), 241190(2027-04-16), 241325(2027-04-16), 241328(2027-04-25), 241336(2027-04-29),
241464(2027-05-07), 241471(2027-05-27), 241553(2027-06-05), 242019(2027-06-28),
242023(2027-06-12), 242057(2027-06-20), 242056(2027-06-20), 242112(2027-06-26),
242160(2027-07-25), 242321(2027-07-08), 242493(2027-08-01), 242596(2027-09-20),
242693(2027-11-06);
80238/07640142811879/230895(2025-11-23), 240128(2026-05-31), 240276(2026-05-31), 240532(2026-05-31), 240658(2026-09-30), 241076(2026-09-30), 241330(2026-09-30), 241548(2026-09-30), 241768(2026-09-30), 241911(2026-09-30), 242117(2026-09-30), 242494(2026-09-30), 242521(2026-09-30), 242519(2026-05-31), 242520(2026-09-30);
80239/07640142811886/230896(2025-11-23), 231231(2026-06-13), 231410(2026-06-13), 231527(2026-08-31), 231883(2026-10-19), 232029(2026-08-31), 232028(2026-10-19), 240129(2026-11-30), 240278(2026-11-30), 240557(2027-01-22), 240746(2027-01-22), 240794(2027-02-28), 241077(2027-04-08), 241188(2027-04-08), 241462(2027-05-03), 241523(2027-05-03), 241767(2027-06-26), 241910(2027-06-26), 242159(2027-08-09), 242322(2027-09-10), 242518(2027-09-10), 242694(2027-10-25), 242695(2027-10-25) |
Recalling Firm/
Manufacturer |
Bard Peripheral Vascular Inc
1625 W 3rd St Bldg 1
850 W. Rio Salado Prkwy.
Tempe AZ 85281-2438
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| For Additional Information Contact |
480-303-2602 |
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Manufacturer 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. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | On 2/5/2025, "URGENT: MEDICAL DEVICE CORRECTION" notices were sent to customers informing them of the following:
1) In order to minimize risks of illness or injury, please review the updates to the eIFU in their entirety. The updated eIFU can be found on BD's website at https://www.bardpv.com/Rotarex-IFU.php
2) Firm recommends that end users review the updated on-line, on-demand training on the safe and effective use of the Rotarex Atherectomy System, reflecting the recent eIFU updates. The online education may be completed by registering on the BDLA Learning Management System https://academy.bd.com.
3) If possible, post this notice with the stored product as evidence of the updated eIFU.
4) Share this notification with all users within your facility network of the product to ensure they are also aware of the updated eIFU. This correction notice should be shared with anyone who needs to be aware within your organization and forwarded to any organization where potentially affected devices have been transferred.
5) Complete and return the response form via email to BDRC20@bd.com
Report any complaints experienced with the use of this product to the firm's Regional Complaint Center: 1-844-8BD-LIFE (1-844-823-5433) Say "Product Complaints" when prompted Mon-Fri 8:00am to 5:00pm CT
Email: productcomplaints@bd.com
For additional information regarding Advance Clinical Education and Training Programs, please email the Advance Team at bdpi.advance@bd.com
Distributors were provided with a copy of the customer communication (correction notice) and asked to provide a copy to all customers on BD's behalf.
If you have any questions, call 480-303-2602.
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| Quantity in Commerce | 15,755 |
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| 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
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = MCW
510(K)s with Product Code = MCW
510(K)s with Product Code = MCW
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