FDA Device recall Z-2138-2013
Boston Scientific, FlextomeTM Cutting BalloonTM, Sterilized using irradiation: 1) 4.00mm x 15mm FlextomeTM Cutting BalloonTM MonorailTM Mic…
- FDA Device
- Class II
- terminated
- Published 2013-09-11
On 2013-09-11 the FDA classified a Class II recall of Boston Scientific, FlextomeTM Cutting BalloonTM, Sterilized using irradiation: 1) 4.00mm x 15mm FlextomeTM Cutting BalloonTM MonorailTM Mic… by Boston Scientific, citing 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 Fle….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2138-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-07-31 |
| Published | 2013-09-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Boston Scientific |
| Distribution | 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 |
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
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
Identifiers
| code_info | UPN # Catalogue # Lot # H749CBM3400150 CBM340015 15777251, 15898645, 16125358. H74…UPN # Catalogue # Lot # H749CBM3400150 CBM340015 15777251, 15898645, 16125358. H749RB4400150 RB440015 15780571. H749CBO3400150 CBO340015 15854224. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2138-2013%22
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