Recall Z-1099-2018
Boston Scientific Corporation · initiated December 12, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Malecot Nephrostomy Catheter System, Product Number: M001224110, GTIN: 08714729030980 The Malecot and the Stenting Malecot Catheters are designed for percutaneous drainage within the renal collecting system while maintaining external access. The Stenting Malecot Nephrostomy Catheter with its extended tip is also designed for internal drainage from the ureteropelvic junction to the bladder.
Codes / lots: Expiration Date Range: 2/28/2018 - 6/30/2020; Batch: 17885402 19389759 20484324 18312368 19423001 20602275 18795228 19652457 20346010 19009720 19682505 20484324 19104130 19910674 20602275 19247419 20346010
Reason for recall
Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
FDA-determined cause: Under Investigation by firm
Action taken
The firm, Boston Scientific, sent an "Urgent Medical Device Product Removal - Immediate Action Required" letter dated 12/12/2017 to its consignees. The letter described the product, problem and actions to be taken. The consignees were instructed to: identify and remove all affected batches from your inventory; immediately discontinue use of and segregate the affected product, and return it to Boston Scientific. Distributors were notified that this removal is to the customer level and asked to notify any customers who received affected product. Consignees were asked to complete and return the Replay Verification Tracking Form (even if you do not have any product to return) via email: BSCFieldActionCenter@bsci.com or Fax to: Field Action Center at 1-866-213-1806. If you have any questions, your local Sales Representative can answer any questions that you may have regarding this removal or contact Vice President , Regulatory Affairs at 508-683-4398 or email: Donna.Gardner@bsci.com or BSCFieldActionCenter@bsci.com.
Details
- Recall number
- Z-1099-2018
- Initiated
- December 12, 2017
- Terminated
- October 24, 2019
- Product code
- GBW – Catheter, Peritoneal
- Quantity
- 422
- Distribution
- Worldwide Distribution: US (nationwide) in the following: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KA, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, including the District of Columbia and Puerto Rico; and countries of: Argentina, Bolivia, Brazil, Canada, Chile, Costa Rica, Dominican Republic, Ecuador, El Salvador…
- Recalling firm
- Boston Scientific Corporation, Marlborough, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1100-2018 Class II | Malecot Nephrostomy Catheter Set, Product Number: M0064101000, GTIN: 08714729005261 The…Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use. | 12/12/2017Terminated |
| Z-1101-2018 Class II | Malecot Nephrostomy Catheter Set, Product Number: M0064101010, GTIN: 08714729005278 The…Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use. | 12/12/2017Terminated |
| Z-1102-2018 Class II | Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101040, GTIN:…Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use. | 12/12/2017Terminated |
| Z-1103-2018 Class II | Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101050, GTIN:…Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use. | 12/12/2017Terminated |
| Z-1104-2018 Class II | Percutaneous Access Set, Product Number: M0064201150, GTIN: 08714729009757 The Malecot…Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use. | 12/12/2017Terminated |