Boston Scientific — Class II medical device recall Z-2137-2013
Terminated recall by Boston Scientific Corporation, reported 2013-09-11, distributed in AL, AR, AZ, CA, CO, CT, DC, DE…. Boston Scientific is initiating a recall removal of the 4.0mm x 15mm size of Small Peripheral Cutting Balloon
| Recall number | Z-2137-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Maple Grove, MN, United States |
| Recall initiated | 2013-07-31 |
| Classified | 2013-09-03 |
| Reported by FDA | 2013-09-11 |
| Terminated | 2015-01-27 |
| Distributed | AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV |
| Countries outside the US | AT, AU, BE, BR, CA, CH, CN, CO, CZ, DE, DK, DZ, ES, FI, FR, GB, GR, HK, IE, IL, IN, IT, JP, KR, LV, NL, NO, PA, PL, SA, SE, TR, TW, ZA |
| Quantity | 1,331 |
| Lot numbers | 15688199, 15735527, 15756145, 15774378, 15778169, 15788826, 15812347, 15824636, 15825277, 15836626, 15873338, 15891705, 15931291, 15945240, 15992736, 16057260, 16066536, 16141255, M001PCBM4015140F0, M001PCBO4015140F0 |
| Model numbers | BPM4015140F, M001PCBM4015140F0, PCBM4015140F, PCBO4015140F |
Product
Boston Scientific, Small Peripheral Cutting BalloonTM, Sterilized using irradiation: The Peripheral Cutting Balloon Catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) of obstructive lesions of synthetic or native arteriovenous dialysis fistulae. 1) 4.00mm x 15mm Small Peripheral Cutting BalloonTM MonorailTM Microsurgical Dilatation Device, UPN #001BPM4015140F0, Catalogue # BPM4015140F & UPN # M001PCBM4015140F0, Catalogue # PCBM4015140F. 2) 4.00mm x 15mm Small Peripheral Cutting BalloonTM Over-the-Wire Microsurgical Dilatation Device, UPN # M001PCBO4015140F0, Catalogue # PCBO4015140F.
Reason for recall
Boston Scientific is initiating a recall removal of the 4.0mm x 15mm size of Small Peripheral Cutting Balloon (Monorail and Over-the-Wire) Microsurgical Dilatation Devices and Flextome Cutting Balloon (Monorail and Over-the-Wire) Microsurgical Dilation Devices. Boston Scientific has determined that users may experience significant difficulty or inability to remove the protector cap from the devic
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-2137-2013. 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.