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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65317

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 28, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Boston Scientific Corporation

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

2 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 2

NephroMax high Pressure Nephrostomy Balloon Catheter. Material Number/Catalog Number: M0062101400/210-140, M062101440/210144 Dilation of the nephrostomy tract.

Z-1672-2013
Recall number
Z-1672-2013
Initiated
May 28, 2013
Classification
Class II
Status
Terminated
Quantity
27

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter.

Code information

Lot Number: 15875861, 15875860, 15875299, 15872797, 15872799, 15872798

Distribution pattern

Worldwide distribution: USA (nationwide) including states of: NJ, NY, OH, IL, MI, MD, MA and countries of: Denmark, Great Britain, and Spain.

device · product 2 of 2

NephroMax high Pressure nephrostomy Balloon Catheter Kit. Material Number/Catalog Number: M0062101600/210-160, M0062101640/210-164 Dilation of the nephrostomy tract.

Z-1673-2013
Recall number
Z-1673-2013
Initiated
May 28, 2013
Classification
Class II
Status
Terminated
Quantity
15 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter.

Code information

Lot Number: 15982017, 15963887, 16034014

Distribution pattern

Worldwide distribution: USA (nationwide) including states of: NJ, NY, OH, IL, MI, MD, MA and countries of: Denmark, Great Britain, and Spain.