Z-0971-2014Class II

Boston Scientific, Coyote" MONORAIL" PTA Balloon Dilatation Catheter, UPN # H74939185201510, Catalogue #...

Name: Z-0971-2014 Boston Scientific, Coyote" MONORAIL" PTA Balloon Dilatation Catheter, UPN # H74939185201510, Catalogue #...
Creator: Boston Scientific Corporation
Published: 2014-02-04
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2014-02-04 / Terminated / root cause: design

FDA source

Boston Scientific Corporation began a recall of Boston Scientific, Coyote" MONORAIL" PTA Balloon Dilatation Catheter, UPN # H74939185201510, Catalogue # 39185-20151 on 2014-02-04. FDA classified it as Class II and gives the reason as "Boston Scientific is initiating this Recall Removal of one lot of the Coyote" OVER-THE-WIRE PTA Balloon Dilatation Catheter and one lot of the Coyote" MONORAIL" PTA Balloon Dilatation Catheter. Boston Scientific has...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0971-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-04
Posted: 2014-02-11
Terminated: 2014-08-04
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific, Coyote" MONORAIL" PTA Balloon Dilatation Catheter, UPN # H74939185201510, Catalogue # 39185-20151.
Product code: LIT Catheter, Angioplasty, Peripheral, Transluminal
Reason for recall: Boston Scientific is initiating this Recall Removal of one lot of the Coyote" OVER-THE-WIRE PTA Balloon Dilatation Catheter and one lot of the Coyote" MONORAIL" PTA Balloon Dilatation Catheter. Boston Scientific has become aware that the balloons of the devices from these lots may not deflate as expected during a procedure. To date, Boston Scientific has received three complaints for this issue. T
Root cause tag: design
FDA root cause: Device Design
Action: Consignees were sent a Boston Scientific " Urgent Medical Device Recall Removal" letter on 2/4/2014. The letter was addressed to Materials Manager and Field Action Contact. The letter described the product involved in the recall and the problem. Advised consignees to segregate the affected lots and return to Boston Scientific in accordance to the enclosed recall instructions. The instructions also requested consignees to complete and return the Account Reply Verification Tracking Form (RVTF).
Quantity in commerce: 35 for both products
Distribution: US: AL, CA, FL, IL, IN, MI, MO, NY, OH, PA, TX. OUS: ITALY, GERMANY, FRANCE, GREAT BRITAIN, NETHERLANDS, WHITE RUSSIA, INDIA, JAPAN.
Product codes and lots: 16310947

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0971-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0969-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-19	2014-02-11
Z-0971-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-19	2014-02-11

Product code LIT

K111295Class II.014 Monorail and Otw Pta Balloon Dilatation CathetersBoston Scientific Corporation / cleared 2011-05-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)