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

Percutaneous Access Set, Product Number: M0064201150 recalled

Boston Scientific is recalling Percutaneous Access Set, Product Number: M0064201150, 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: 12/10/2017 - 10/29/2021; Batch: 16602757 17989189 19103005 16632804 18000051 19156402 16668232 18071028 19272679 16687725 18187908 19323232 16701905 18238926 19338380 16725748 18312539 19374391 16746021 18347202 19419431 16768170 18403711 19510783 16769687 18453529 19543444 16791047 18467224 19596296 16813326 18511816 19622910 16861185 18522401 19652445 16886796 18631119 19672586 16911889 18702248 19824542 16918770 18702249 19884752 16931022 18705836 20001153 16931071 18780195 20091268 16964525 18800088 20118753 17143046 18818625 20198261 17227380 18820391 20288613 17399143 18900337 20321757 17446684 18900338 20477761 17604237 18955686 20753764 17659535 18977772 20789373 17670349 19006930 21009191 17710577 19087159 21046808 17766030 19097822 21316321 17826778

Quantity recalled3762

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-1104-2018
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

Percutaneous Access Set, Product Number: M0064201150, GTIN: 08714729009757 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

Is Percutaneous Access Set, Product Number: M0064201150 recalled?

Yes. Boston Scientific recalled Percutaneous Access Set, Product Number: M0064201150 on 12 Dec 2017. The recall is Class II and its status is Terminated. Recall number Z-1104-2018.

Why was it recalled?

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

Which lots are affected?

Expiration Date Range: 12/10/2017 - 10/29/2021; Batch: 16602757 17989189 19103005 16632804 18000051 19156402 16668232 18071028 19272679 16687725 18187908 19323232 16701905 18238926 19338380 16725748 18312539 19374391 16746021 18347202 19419431 16768170 18403711 19510783 16769687 18453529 19543444 16791047 18467224 19596296 16813326 18511816 19622910 16861185 18522401 19652445 16886796 18631119 19672586 16911889 18702248 19824542 16918770 18702249 19884752 16931022 18705836 20001153 16931071 18780195 20091268 16964525 18800088 20118753 17143046 18818625 20198261 17227380 18820391 20288613 17399143 18900337 20321757 17446684 18900338 20477761 17604237 18955686 20753764 17659535 18977772 20789373 17670349 19006930 21009191 17710577 19087159 21046808 17766030 19097822 21316321 17826778

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

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