Z-0663-2017Class II

Bridge Occlusion Balloon. Model: 590-001 Temporary vessel occlusion of the superior vena cava in applications...

Name: Z-0663-2017 Bridge Occlusion Balloon. Model: 590-001 Temporary vessel occlusion of the superior vena cava in applications...
Creator: Spectranetics Corporation
Published: 2016-10-31
License: https://open.fda.gov/license/

Spectranetics Corp. / initiated 2016-10-31 / Terminated / root cause: packaging

FDA source

Spectranetics Corporation began a recall of Bridge Occlusion Balloon. Model: 590-001 Temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency... on 2016-10-31. FDA classified it as Class II and gives the reason as "Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon due to potentially compromised integrity of the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0663-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-31
Posted: 2016-11-28
Terminated: 2017-04-18
Recalling firm: Spectranetics Corp.
Product: Bridge Occlusion Balloon. Model: 590-001 Temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage. Any use for procedures other than those indicated in the instructions is not recommended.
Product code: MJN Catheter, Intravascular Occluding, Temporary
Reason for recall: Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon due to potentially compromised integrity of the outer sterile packaging.
Root cause tag: packaging
FDA root cause: Packaging
Action: Spectranectics sent an Urgent Medical Device Recall letter dated October 31, 2016, to all affected consignees. Consignees were instructed to discontinue use of the potentially impacted lots and return the product for replacement. Consignees were also instructed to complete the attached Acknowledgement and Receipt Form to facilitate the product return of any remaining product in inventory. Customers with questions were instructed to call 1-800-231-0978, Option 2. For questions regarding this recall call 719-651-8517.
Quantity in commerce: 873 units
Distribution: Worldwide Distribution - US (nationwide and PR) Internationally to Austria, Belgium, Cyprus, Denmark, France, Germany, Hungary, Italy, Netherlands, Norway, Poland, Spain, Sweden, Switzerland, United Kingdom, Australia, Bahrain, Brazil, Canada, Chile, Colombia, Dominican Republic, Israel, Japan, Kuwait, Taiwan, Thailand.
Product codes and lots: FMN16E11A; FMN16E18A; FMN16E25A; FMN16F01A; FMN16F08A; FMN16F15A FMN16F22A; FMN16G13A; FMN16G19A; FMN16G25A; FMN16H04A; FMN16H23A; FMN16J27A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0663-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0661-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-07	2016-12-01
Z-0662-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-07	2016-12-01
Z-0663-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-07	2016-12-01

Product code MJN

K140775Class IITurbo-Elite Atherectomy Catheters, Turbo Tandem SystemSpectranetics Corporation / cleared 2014-07-23

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)