Z-0576-2020Class II

Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm...

Name: Z-0576-2020 Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm...
Creator: Spectranetics Corporation
Published: 2018-12-07
License: https://open.fda.gov/license/

Spectranetics Corp. / initiated 2018-12-07 / Terminated / root cause: manufacturing process

FDA source

Spectranetics Corporation began a recall of Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm, REF 2027-2515, Sterile, Rx. The firm name on the... on 2018-12-07. FDA classified it as Class II and gives the reason as "The incorrect outer carton box was used for the product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0576-2020
Classification: Class II
Status: Terminated
Initiated: 2018-12-07
Posted: 2019-11-26
Terminated: 2020-10-27
Recalling firm: Spectranetics Corp.
Product: Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm, REF 2027-2515, Sterile, Rx. The firm name on the label is Spectranetics Corporation, Fremont, CA.
Product code: NWX Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring
Reason for recall: The incorrect outer carton box was used for the product.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The recalling firm issued an undated Dear Healthcare Professional letter via FedEx informing the consignee of the issue, the risk to health, and the actions to be taken. Return of the device was requested.
Quantity in commerce: 3 catheters
Distribution: Distribution was made to IA, MI, and NJ. There was government distribution. There was no military/foreign distribution.
Product codes and lots: AngioSculpt PTCA lot #G18090030.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0576-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0576-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-26

Product code NWX

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)