CLASS II Device recall · Reported 28 Mar 2018 · FDA Enforcement Report

Malecot Nephrostomy Catheter Set, Product Number: M0064101010 recalled

Boston Scientific is recalling Malecot Nephrostomy Catheter Set, Product Number: M0064101010, distributed nationwide in the US. The recall was initiated on 12 Dec 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesExpiration Date Range: 1/22/2018 - 10/4/2021; Batch: 16682347 18705536 20623819 16893775 18773341 20658861 16943409 18876327 20685659 17003572 18898595 20735791 17017122 18987890 20798226 17075064 19058167 20830240 17184857 19515680 20884480 17192710 19900108 20909296 17603504 20094213 20942365 17703884 20261038 21055683 17797369 20312726 21129580 17990644 20401204 21157953 18084498 20458382 21179391 18095911 20491743 21218849 18691891 20517726

Quantity recalled1716

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-1101-2018
FDA event ID: 79424
Recalling firm: Boston Scientific, Marlborough, MA
Classification: Class II
Status: Terminated
Recall initiated: 12 Dec 2017
FDA classified: 18 Mar 2018
Reported: 28 Mar 2018
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Heart & Vascular Devices

Timeline

12 Dec 2017	Recall initiated by company
18 Mar 2018	Classified by FDA	+96 days
28 Mar 2018	Published in enforcement report	+10 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Malecot Nephrostomy Catheter Set, Product Number: M0064101010, GTIN: 08714729005278 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

Where it was distributed

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.

Nationwide Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Iowa Illinois Indiana Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Expiration Date Range: 1/22/2018 - 10/4/2021; Batch: 16682347 18705536 20623819 16893775 18773341 20658861 16943409 18876327 20685659 17003572 18898595 20735791 17017122 18987890 20798226 17075064 19058167 20830240 17184857 19515680 20884480 17192710 19900108 20909296 17603504 20094213 20942365 17703884 20261038 21055683 17797369 20312726 21129580 17990644 20401204 21157953 18084498 20458382 21179391 18095911 20491743 21218849 18691891 20517726

Where was it sold?

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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

5 other products · FDA event 79424

This product is part of a recall event; the main page for the event is Percutaneous Access Set, Product Number: M0064201150 recalled.

Reported	Class	Recall	Company	Reason	Where
28 Mar 2018	CLASS II	Percutaneous Access Set, Product Number: M0064201150 recalled	Boston Scientific	Device Malfunction	Nationwide
28 Mar 2018	CLASS II	Re-Entry" Malecot Nephrostomy Catheter Set, Product Number recalled	Boston Scientific	Device Malfunction	Nationwide
28 Mar 2018	CLASS II	Malecot Nephrostomy Catheter Set, Product Number: M0064101000 recalled	Boston Scientific	Device Malfunction	Nationwide
28 Mar 2018	CLASS II	Malecot Nephrostomy Catheter System, Product Number: M001224110 recalled	Boston Scientific	Device Malfunction	Nationwide
28 Mar 2018	CLASS II	Re-Entry" Malecot Nephrostomy Catheter Set, Product Number recalled	Boston Scientific	Device Malfunction	Nationwide

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