Boston Scientific — Class II medical device recall Z-2138-2013
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-2138-2013 |
|---|---|
| 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 | 340 |
| Lot numbers | 15777251, 15780571, 15854224, 15898645, 16125358, CBM340015, CBO340015, H749CBM3400150, H749CBO3400150, H749RB4400150, RB440015 |
| Model numbers | 15777251, 15780571, 15854224, 15898645, 16125358, CBM340015, CBO340015, H749CBM3400150, H749CBO3400150, H749RB4400150, RB440015 |
Product
Boston Scientific, FlextomeTM Cutting BalloonTM, Sterilized using irradiation: 1) 4.00mm x 15mm FlextomeTM Cutting BalloonTM MonorailTM Microsurgical Dilatation Device, UPN #H749CBM3400150 Catalogue # CBM340015 & UPN# H749RB4400150 Catalogue # RB440015 2) 4.00mm x 15mm FlextomeTM Cutting BalloonTM Over-the-Wire Microsurgical Dilatation Device, UPN # H749CBO3400150, Catalogue # CBO340015 The Flextome Cutting Balloon Device is indicated for dilatation of stenoses in coronary arteries for the purpose of improving myocardial perfusion in those circumstances where a high pressure balloon resistant lesion is encountered. In addition, the target lesion should possess the following characteristics: " Discrete (< 15 mm in length), or tubular (10 to 20 mm in length) " Reference vessel diameter (RVD) of 2.00 mm - 4.00 mm " Readily accessible to the device " Light to moderate tortuosity of proximal vessel segment " Nonangulated lesion segment (< 45¿) " Smooth angiographic contour " Absence of angiographically visible thrombus and/or calcification.
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
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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.