Z-0262-2018Class II

Rezum System, Vapor BPH Ablation System, Model Number D2201-003. NxThera Inc. 7351 Kirkwood Lane Suite 138...

Name: Z-0262-2018 Rezum System, Vapor BPH Ablation System, Model Number D2201-003. NxThera Inc. 7351 Kirkwood Lane Suite 138...
Creator: Nxthera
Published: 2017-07-28
License: https://open.fda.gov/license/

Nxthera, Inc. / initiated 2017-07-28 / Terminated / root cause: manufacturing process

FDA source

NXTHERA began a recall of Rezum System, Vapor BPH Ablation System, Model Number D2201-003. NxThera Inc. 7351 Kirkwood Lane Suite 138 Maple Grove, MN 55369 USA. Intended to relieve... on 2017-07-28. FDA classified it as Class II and gives the reason as "Needle Bond may not be able to withstand the tension force applied when the shaped needle is deployed into and retracted from prostate tissue to deliver treatments". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0262-2018
Classification: Class II
Status: Terminated
Initiated: 2017-07-28
Posted: 2017-12-18
Terminated: 2018-08-01
Recalling firm: Nxthera, Inc.
Product: Rezum System, Vapor BPH Ablation System, Model Number D2201-003. NxThera Inc. 7351 Kirkwood Lane Suite 138 Maple Grove, MN 55369 USA. Intended to relieve symptoms, obstructions, and reduce prostate tissue associated with benign prostatic hyperplasia (BPH). It is indicated for men greater or equal to 50 years of age with a prostate volume greater than or equal to 30cm3 and less than or equal to 80cm3. The Rezum System is also indicated for treatment of prostates with hyperplasia of the central zone and/or a median lobe.
Product code: KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Reason for recall: Needle Bond may not be able to withstand the tension force applied when the shaped needle is deployed into and retracted from prostate tissue to deliver treatments.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Customers were notified initially by sales representatives on or about July 18, 2017. Any affected devices were to be returned to NxThera. Additionally, a formal recall letter was mailed to customers on approximately July 28, 2017. NxThera's telephone contact information and FEDEX number will be provided on the verification form. For further questions, please call (763) 515-2084..
Quantity in commerce: 113 units total
Distribution: USA Distribution to the states of : AL, AZ, CA, CO, FL, GA, IL, MA, MI, MN, MO, NE, NJ, NY, OH, PA, TN, UT, WA.
Product codes and lots: UDI 08855757006010. Lot Number of Outside Cases (Pack Lot) 2017020920 with Lot Number of Inside Boxes (Product Lot) 2017011612 and Exp Date 2018-01-31: Lot Number of Outside Cases (Pack Lot) 2017030286 with Lot Number of Inside Boxees (Product Lot) 2017011187 and Exp Date 2018-01-31.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0262-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0262-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-27	2017-12-18

Product code KNS

K160417Class IIRezum SystemNxthera, Inc. / cleared 2016-03-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)