Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported February 17, 2016
2.3mm Turbo-Power OTW, Manual, Model No 423-050 Product Usage The Turbo-Power System (Laser Atherectomy Catheter) is a laser atherectomy device designed for use with the CVX-300" Excimer Laser System. The Turbo-Power Laser Atherectomy Catheter is a sterile, single use, prescription only device used for peripheral atherectomy. Turbo-Power is used exclusively with SPNC s CVX 300" Excimer Laser System and is a Type CF device, Defibrillation proof. Turbo-Power is a laser atherectomy catheter design
The product is labeled with an expiration date that is past its shelf life.
Spectranetics Corp. recalled 2.3mm Turbo-Power OTW, Manual, Model No 423-050 Product Usage The Turbo-Power System (La… - a moderate-severity action.
2.3mm Turbo-Power OTW, Manual, Model No 423-050 Product Usage The Turbo-Power System (La… was recalled by Spectranetics Corp. in February 17, 2016. Reason: The product is labeled with an expiration date that is past its shelf life.. Check the official notice for the remedy. Verify recall #Z-0758-2016 with the FDA Devices before acting.
The recall
Spectranetics Corp. issued this moderate-severity FDA Devices recall-The product is labeled with an expiration date that is past its shelf life..
- Moderate
- severity level
- 8 units
- affected scope
- Class II
- classification
- February 17, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0758-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0758-2016) was formally reported on February 17, 2016, with the manufacturer initiating the action on January 15, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Spectranetics Corp. is listed as the recalling firm, operating out of Colorado Springs, CO. Federal records list the affected scope as 8 units.
The documented reason for this recall is: The product is labeled with an expiration date that is past its shelf life. Distribution data in the federal record shows the product reached: Nationwide distribution to Florida, North Carolina and Pennsylvania.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
8 units
Related Recalls
6
3 from same agency
Product description
2.3mm Turbo-Power OTW, Manual, Model No 423-050 Product Usage The Turbo-Power System (Laser Atherectomy Catheter) is a laser atherectomy device designed for use with the CVX-300" Excimer Laser System. The Turbo-Power Laser Atherectomy Catheter is a sterile, single use, prescription only device used for peripheral atherectomy. Turbo-Power is used exclusively with SPNC s CVX 300" Excimer Laser System and is a Type CF device, Defibrillation proof. Turbo-Power is a laser atherectomy catheter designed for treatment of de novo or restenotic lesions in native infrainguinal arteries and for the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, with adjunctive Percutaneous Transluminal Angioplasty (PTA). Turbo-Power is used to directionally ablate infrainguinal concentric and eccentric lesions in vessels that are 3.5 mm or greater in diameter. The device is comprised of three parts: the working length of the catheter shaft (also the applied part), the motor drive unit (MDU), and the proximal laser shaft which connects the catheter fiber optics to the CVX-300" Excimer Laser System.
Reason for recall
The product is labeled with an expiration date that is past its shelf life.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0758-2016 |
| Date reported | February 17, 2016 |
| Date initiated | January 15, 2016 |
| Recalling firm | Spectranetics Corp. |
| Firm location | Colorado Springs, CO |
| Affected scope | 8 units |
| Distribution | Nationwide distribution to Florida, North Carolina and Pennsylvania. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0758-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
2.3mm Turbo-Power OTW, Manual, Model No 423-050 Product Usage The Turbo-Power System (Laser Atherectomy Catheter) is a laser atherectomy device designed for use with the CVX-300" Excimer Laser System. The Turbo-Power Laser Atherectomy Catheter is a sterile, single use, prescription only device used for peripheral atherectomy. Turbo-Power is used exclusively with SPNC s CVX 300" Excimer Laser System and is a Type CF device, Defibrillation proof. Turbo-Power is a laser atherectomy catheter designed for treatment of de novo or restenotic lesions in native infrainguinal arteries and for the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, with adjunctive Percutaneous Transluminal Angioplasty (PTA). Turbo-Power is used to directionally ablate infrainguinal concentric and eccentric lesions in vessels that are 3.5 mm or greater in diameter. The device is comprised of three parts: the working length of the catheter shaft (also the applied part), the motor drive unit (MDU), and the proximal laser shaft which connects the catheter fiber optics to the CVX-300" Excimer Laser System.. Recalled by Spectranetics Corp.. Units affected: 8 units.
Why was this product recalled? ▼
The product is labeled with an expiration date that is past its shelf life.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 17, 2016. Severity: Moderate. Recall number: Z-0758-2016.
Where was the recalled product distributed? ▼
Distribution: Nationwide distribution to Florida, North Carolina and Pennsylvania..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0758-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 17, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.