Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77797

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 28, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
NXTHERA

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-0262-2018
Recall number
Z-0262-2018
Initiated
July 28, 2017
Classification
Class II
Status
Terminated
Recalling firm
NXTHERA
Quantity
113 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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.

Distribution pattern

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.

Field note

Send feedback

We'll only use this to respond to your feedback.