# FDA recall Z-1102-2018

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

## Product

Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101040, GTIN: 08714729008446     The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography " Pressure/perfusion study (Whitaker test) Therapeutic Indications: " Nephrostomy catheter drainage " Perfusion chemolysis of renal stones " Percutaneous nephrolithotomy " Percutaneous resection and coagulation of urothelial tumors

## 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-1102-2018
- **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-1102-2018

## Citation

> AI Analytics. FDA recall Z-1102-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1102-2018. Source: US FDA. Licensed CC0.

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