Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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.

FDA Recall Z-0576-2020 · Posted None

Recalling FirmSpectranetics Corporation
Recall StatusTerminated
Product CodeNWX
Date Initiated2018-12-07
Date Terminated2020-10-27
Product Quantity3 catheters

Reason for Recall

The incorrect outer carton box was used for the product.

Firm 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.

Root Cause

Process control

Distribution Pattern

Distribution was made to IA, MI, and NJ. There was government distribution. There was no military/foreign distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑