Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm — Class I medical device recall Z-1756-2019
Terminated recall by Cook Inc., reported 2019-06-26, distributed nationwide. Multiple complaints were received for balloons bursting below the rated burst pressure. Potential adverse even
| Recall number | Z-1756-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Inc., Bloomington, IN, United States |
| Recall initiated | 2019-05-24 |
| Classified | 2019-06-17 |
| Reported by FDA | 2019-06-26 |
| Terminated | 2019-10-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, BE, CH, DE, DK, ES, FI, GB, IT, NL, NO, PL, SE, ZA |
| Quantity | 34 |
| Lot numbers | 9234424, 9331618 |
| Model numbers | ASB5-35-50-6-4, G35248 |
Product
Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/50cm, Catalog Number ASB5-35-50-6-4, REF Number G35248 Product Usage: The Advance Enforcer 35 Focal-Force PTA Balloon Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral, as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the cerebral or coronary vasculature.
Reason for recall
Multiple complaints were received for balloons bursting below the rated burst pressure. Potential adverse events that may occur if an affected product is used include a delay in the procedure, additional intervention, vessel injury, and balloon fragmentation in the patient.
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-1756-2019. 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.