Food, drugs, devices › Spectranetics Corporation
Device recall: Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm, REF 2027-251
FDA enforcement event 84057 is a device recall by Spectranetics Corporation of Fremont, CA, initiated 7 Dec 2018 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 27 Oct 2020. Initiation: voluntary: firm initiated. Spectranetics Corporation has 10 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Spectranetics Corporation, Fremont, CA.
Reason for recall
"The incorrect outer carton box was used for the product."
Distribution
"Distribution was made to IA, MI, and NJ. There was government distribution. There was no military/foreign distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0576-2020 | 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. | 3 catheters | Class II | Terminated | 4 Dec 2019 |
Context
Other enforcement events for Spectranetics Corporation
All 10 events for Spectranetics Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The incorrect outer carton box was used for the product."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Distribution was made to IA, MI, and NJ. There was government distribution. There was no military/foreign distribution."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 27 Oct 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.