Cordis RenLane Renal Denervation Catheter Recalled for Potential Tip Damage
Cordis is recalling 98 RenLane Renal Denervation Catheters because the helical tip may be damaged if the arterial access device valve is not fully open.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of harm (potential damage to the catheter tip) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Cordis Corporation is recalling 98 units of the RenLane Renal Denervation Catheter (Catalog No. D135601). The device is used in adult patients with drug-resistant hypertension to denervate renal arteries and reduce blood pressure.
The recall was initiated because potential damage may occur to the helical tip of the catheter if the hemostasis valve of the arterial access device is not fully open before the catheter is inserted or withdrawn. The affected lots are 15958389LA, 15959088LA, 15959090LA, 15968753LA, 15968806LA, 15968810LA, and 15968813LA (Expiration Date 8/31/2014) and 15976735L, 15976820L, 15976823L, 15978174L, 15978179L, 159784180L, and 15978181L (Expiration Date 9/30/2014).
The product was distributed in Germany only. Healthcare providers should check their inventory for these specific lot numbers and stop using the affected devices.
The recalled product
- Product
- RenLane Renal Denervation Catheter; Cat No.: D135601. Used in adults patients (>18 years) with drug resistant hypertension to denervate the renal arteries to reduce blood pressure.
- Manufacturer
- Cordis Corporation
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 98
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (14)
- Model Number: D135601 Lots #'s 15958389LA
- 15959088LA
- 15959090LA
- 15968753LA
- 15968806LA
- 15968810LA
- and 15968813LA
- with Exp Date 8/31/2014 Lots #'s 15976735L
- 15976820L
- 15976823L
- 15978174L
- 15978179L
- 159784180L
- and 15978181L with Exp Date 9/30/2014
Distribution
Distribution scope not specified by the agency.
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