Percutaneous Insertion Tray For Use with: Arrow Ultra 8 IAB (Intra Aortic Balloon) Catheters Model: IAK-05845
FDA device recall Z-0969-2011 · posted 2010-12-23 · Terminated
Recall details
- Recalling firm
- Arrow International, Inc., Division of Teleflex Medical Inc.
- Reason for recall
- SuperArrow Flex IAB catheter becomes stuck in the sheath, unable to move the IAB catheter forward or backward, causing a delay in therapy, bleeding or arterial injury.
- Action taken
- Arrow international initiated a voluntary recall on 12/21/10 by letter requesting users to discontinue use and return all unused 5800 Series IAB with SuperFlex Introducers to Arrow. This field action supercedes the Safety Alert IAB 'Stuck in Sheath' letter issued on 10/8/2010. Questions should be directed towards their local sales representative or the IABP support Line at 1-866-396-2111 or 1-617-389-6400.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DSP
- Quantity affected
- 714
- Distribution
- Worldwide Distribution -- USA, Canada, Australia, Belgium, Czechoslovakia, Germany, Russia, Spain, Finland, France, Great Britain, Hungary, Italy, Netherlands, Poland, Saudi Arabia, Switzerland, Brazi
- Date initiated
- 2010-10-11
- Date posted
- 2010-12-23
- Date terminated
- 2015-02-05
- Location
- Everett, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARROW INTRA-AORTIC BALLOON (IAB) CATHETER WITH A FIBER OPTIC SENSOR AND A MEASUREMENT SYSTEM, MODELS IAB-05830-F,IAB5840 (K021462) | Arrow Intl., Inc. | 2002-06-06 |
| ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL (K000729) | Arrow Intl., Inc. | 2000-05-19 |