Percutaneous Insertion Tray — Class I medical device recall Z-1063-2016
Terminated recall by Arrow International, Inc., Division of Teleflex Medical Inc., reported 2016-03-16, distributed nationwide. The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for b
| Recall number | Z-1063-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arrow International, Inc., Division of Teleflex Medical Inc., Everett, MA, United States |
| Recall initiated | 2016-02-10 |
| Classified | 2016-03-10 |
| Reported by FDA | 2016-03-16 |
| Terminated | 2021-05-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BE, BR, BS, CA, CL, CN, CO, EC, GT, HK, ID, IN, JP, KR, MX, MY, NP, NZ, PA, PE, PH, PK, SG, TH, TT, TW, UY, VN, ZA |
| Lot numbers | 18F14A0037, 18F14B0040, 18F14E0027, 18F14F0027, 18F14F0028 |
Product
Percutaneous Insertion Tray; Product Code: IAK-S7IT The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.
Reason for recall
The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1063-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.