# FDA recall Z-1099-2018

> **Boston Scientific Corporation** · Class II · device recall initiated 2017-12-12.

## 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.

## Reason for recall

Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.

## 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, Guatemala, Mexico, Panama, Peru, Venezuela, Australia, Bangladesh, Botswana, China, Kuwait, Lebanon, Macau, Malaysia, Philippines, Saudi Arabia, Singapore, South Africa, South Korea, Turkey, United Arab Emirates, and Zimbabwe.

## Key facts

- **Recall number:** Z-1099-2018
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-12
- **Report date:** 2018-03-28
- **Termination date:** 2019-10-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Marlborough, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1099-2018

## Citation

> AI Analytics. FDA recall Z-1099-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1099-2018. Source: US FDA. Licensed CC0.

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