CLASS II Device recall · Reported 2 Aug 2017 · FDA Enforcement Report
Medtronic Visualase(R) Cooled Laser Applicator System (Vclas) TIP recalled
Medtronic Navigation is recalling Medtronic Visualase(R) Cooled Laser Applicator System (Vclas) TIP, distributed in 7 states. The recall was initiated on 7 Jun 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2755-2017
- FDA event ID
- 77623
- Recalling firm
- Medtronic Navigation, Louisville, CO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Jun 2017
- FDA classified
- 21 Jul 2017
- Reported
- 2 Aug 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 7 Jun 2017 | Recall initiated by company | |
| 21 Jul 2017 | Classified by FDA | +44 days |
| 2 Aug 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Medtronic has become aware that the VCLAS 15MM TIP cap, also referred to as Tuohy Borst Adapter (TBA), may not be capable of creating a seal around the optical fiber to ensure adequate saline flow through the cooling system. When the TBA is unable to seal around the optical fiber, low retention force to the optical fiber may occur, causing saline to leak out of the TBA.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Medtronic Visualase(R) Cooled Laser Applicator System (VCLAS) 15MM TIP, REF 9735561, (1) Laser Diffusing Fiber - 600um Core, 15mm Tip, (1) Cooling Catheter with 3M(TM) SteriStrip(TM), (1) Pump Tubing Set, (1) Drainage Bag. Medtronic Navigation, Inc. Louisville, CO 80027
Where it was distributed
US Distribution to the states of : CA, GA, MN, FL, NY, IL, TX
CaliforniaFloridaGeorgiaIllinoisMinnesotaNew YorkTexas
Stores named: Walmart
Questions about this recall
Is Medtronic Visualase(R) Cooled Laser Applicator System (Vclas) TIP recalled?
Yes. Medtronic Navigation recalled Medtronic Visualase(R) Cooled Laser Applicator System (Vclas) TIP on 7 Jun 2017. The recall is Class II and its status is Terminated. Recall number Z-2755-2017.
Why was it recalled?
Medtronic has become aware that the VCLAS 15MM TIP cap, also referred to as Tuohy Borst Adapter (TBA), may not be capable of creating a seal around the optical fiber to ensure adequate saline flow through the cooling system. When the TBA is unable to seal around the optical fiber, low retention force to the optical fiber may occur, causing saline to leak out of the TBA.
Which lots are affected?
Lot Numbers: 211158059, 211560973, 211959879, 12473141, 212707035, 211158151, 211594328, 211977586, 212503634, 212745660, 211158152, 211599898, 211987873, 212504463, 212796559, 211181212, 211628257, 212127654, 212549456, 212912501, 211181547,211908695, 212141557, 212553428, 211184941, 211916062, 212148368, 212632884,211555011, 211926889, 212434500, 212647830, 211555017, 211950736, 212438405, 212701679
Where was it sold?
US Distribution to the states of : CA, GA, MN, FL, NY, IL, TX
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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