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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95124

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

Open FDA event record

Event summary

Timeline bucket
August 01, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
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

31 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 31

WALLFLEX FC ESO STENT RMV 18X103MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516210

Z-3265-2024
Recall number
Z-3265-2024
Initiated
August 01, 2024
Classification
Class II
Status
Ongoing
Quantity
79 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

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

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

Code information

GTIN: 08714729854470 Lot Numbers: 33045962, 33120912, 33137308, 33208045, 33245087

Distribution pattern

Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.

device · product 2 of 31

WALLFLEX FC ESO STENT RMV 18X123MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516220

Z-3266-2024
Recall number
Z-3266-2024
Initiated
August 01, 2024
Classification
Class II
Status
Ongoing
Quantity
66 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

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

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

Code information

GTIN: 08714729854487 Lot Numbers: 33017652, 33213399, 33256089, 33275531

Distribution pattern

Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.

device · product 3 of 31

WALLFLEX FC ESO STENT RMV 18X153MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516230

Z-3267-2024
Recall number
Z-3267-2024
Initiated
August 01, 2024
Classification
Class II
Status
Ongoing
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

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

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

Code information

GTIN: 08714729854494 Lot Numbers: 33094174

Distribution pattern

Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.

device · product 4 of 31

WALLFLEX FC ESO STENT RMV 23X105MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516240

Z-3268-2024
Recall number
Z-3268-2024
Initiated
August 01, 2024
Classification
Class II
Status
Ongoing
Quantity
146 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

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

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

Code information

GTIN: 08714729854500 Lot Numbers: 32867087, 32980849, 33014126, 33085585, 33128875, 33208047, 33233490, 33275533

Distribution pattern

Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.

device · product 5 of 31

WALLFLEX FC ESO STENT RMV 23X125MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516250

Z-3269-2024
Recall number
Z-3269-2024
Initiated
August 01, 2024
Classification
Class II
Status
Ongoing
Quantity
176 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

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

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

Code information

GTIN: 08714729854517 Lot Numbers: 32809368, 32846904, 32856377, 32867089, 32898068, 32908416, 32914771, 32919348, 32938992, 33058575

Distribution pattern

Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.

device · product 6 of 31

WALLFLEX FC ESO STENT RMV 23X155MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516260

Z-3270-2024
Recall number
Z-3270-2024
Initiated
August 01, 2024
Classification
Class II
Status
Ongoing
Quantity
145 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

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

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

Code information

GTIN: 08714729854524 Lot Numbers: 32752366, 32752367, 32789716, 32919840, 32927193, 32956258, 32994874, 33056529

Distribution pattern

Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.

device · product 7 of 31

WALLFLEX FC ESO STENT RMV LL 18X103- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516270

Z-3271-2024
Recall number
Z-3271-2024
Initiated
August 01, 2024
Classification
Class II
Status
Ongoing
Quantity
77 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

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

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

Code information

GTIN: 08714729905523 Lot Numbers: 32837018, 32946075, 33014125, 33218762

Distribution pattern

Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.

device · product 8 of 31

WALLFLEX FC ESO STENT RMV LL 23X105- Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516300

Z-3272-2024
Recall number
Z-3272-2024
Initiated
August 01, 2024
Classification
Class II
Status
Ongoing
Quantity
40 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

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

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

Code information

GTIN: 08714729905554 Lot Numbers: 32771052, 32846905

Distribution pattern

Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.

device · product 9 of 31

WALLFLEX FC ESO STENT RMV LL 23X125-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516310

Z-3273-2024
Recall number
Z-3273-2024
Initiated
August 01, 2024
Classification
Class II
Status
Ongoing
Quantity
115 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

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

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

Code information

GTIN: 08714729905561 Lot Numbers: 32858862, 32865977, 32898069, 32914769, 32985474, 33256092

Distribution pattern

Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.

device · product 10 of 31

WALLFLEX FC ESO STENT RMV LL 23X155- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516320

Z-3274-2024
Recall number
Z-3274-2024
Initiated
August 01, 2024
Classification
Class II
Status
Ongoing
Quantity
77 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

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

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

Code information

GTIN: 08714729905578 Lot Numbers: 32753933, 32937357, 32987960, 33218763

Distribution pattern

Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.

device · product 11 of 31

WALLFLEX ESOPHAGEAL FC 18/23-25MMX10CM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516700

Z-3275-2024
Recall number
Z-3275-2024
Initiated
August 01, 2024
Classification
Class II
Status
Ongoing
Quantity
231 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

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

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

Code information

GTIN: 08714729778035 Lot Numbers: 32779260, 32790021, 32817917, 32860922, 32906415, 32966005, 32967262, 33026701, 33026703, 33077154, 33077157, 33085584 33147800, 33156072, 33218764, 33256093

Distribution pattern

Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.

device · product 12 of 31

WALLFLEX ESOPHAGEAL FC 18/23-25MMX12CM-- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516710

Z-3276-2024
Recall number
Z-3276-2024
Initiated
August 01, 2024
Classification
Class II
Status
Ongoing
Quantity
124 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

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

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

Code information

GTIN: 08714729778042 Lot Numbers: 32779261, 32820237, 32906416, 33030432, 33077155, 33077156, 33094173, 33137309, 33137313, 33195043

Distribution pattern

Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.

device · product 13 of 31

WALLFLEX ESOPHAGEAL FC 18/23-25MMX15CM- Agile Esophageal Partially Covered and Fully Covered OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516720

Z-3277-2024
Recall number
Z-3277-2024
Initiated
August 01, 2024
Classification
Class II
Status
Ongoing
Quantity
79 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

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

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

Code information

GTIN: 08714729778059 Lot Numbers: 32770266, 32780362, 32865975, 32906417, 32975732, 33017656, 33128876, 33167135

Distribution pattern

Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.

device · product 14 of 31

WALLFLEX ESOPHAGEAL FC 23/28MMX10CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516730

Z-3278-2024
Recall number
Z-3278-2024
Initiated
August 01, 2024
Classification
Class II
Status
Ongoing
Quantity
364 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

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

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

Code information

GTIN: 08714729778066 Lot Numbers: 32770264, 32779262, 32799929, 32799930, 32809367, 32927194, 32946077, 32976902, 32977680, 32977681, 33017674, 33036450 33036451, 33045963, 33064554, 33064555, 33085586, 33130671, 33130672, 33195044, 33195045, 33214280, 33218599, 33266647

Distribution pattern

Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.

device · product 15 of 31

WALLFLEX ESOPHAGEAL FC 23/28MMX12CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516740

Z-3279-2024
Recall number
Z-3279-2024
Initiated
August 01, 2024
Classification
Class II
Status
Ongoing
Quantity
507 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

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

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

Code information

GTIN: 08714729778073 Lot Numbers: 32771050, 32771051, 32789719, 32790020, 32827713, 32837013, 32837014, 32846903, 32856378, 32875122, 32876614, 32888839 32906418, 32914770, 32919349, 32927196, 32928279, 32938993, 33014831, 33038108, 33101459, 33102100, 33119729, 33137310 33137311, 33137312, 33145979, 33176328, 33218760, 33256094, 33266648

Distribution pattern

Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.

device · product 16 of 31

WALLFLEX ESOPHAGEAL FC 23/28MMX15CM-Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516750

Z-3280-2024
Recall number
Z-3280-2024
Initiated
August 01, 2024
Classification
Class II
Status
Ongoing
Quantity
516 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

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

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

Code information

GTIN: 08714729778080 Lot Numbers: 32809369, 32809370, 32820234 ,32829719, 32837015, 32859849, 32888837, 32888838, 32914768, 32919658, 32919659, 32938991 32956256, 32977683, 32980850, 32986659, 32994875, 32998177, 33014830, 33101458, 33119730, 33176329, 33195046, 33195048 33208043, 33208044, 33218761, 33242625, 33266646, 33266649

Distribution pattern

Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.

device · product 17 of 31

WALLFLEX PC ESOPH STENT 18/23MM X 103MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516900

Z-3281-2024
Recall number
Z-3281-2024
Initiated
August 01, 2024
Classification
Class II
Status
Ongoing
Quantity
297 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

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

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

Code information

GTIN: 08714729765240 Lot Numbers: 32759902, 32780160, 32830094, 32865976, 32868557, 32875121, 32891029, 32898065, 32898066, 32906414, 32915745, 32938540 32966004, 32977682, 32985473, 33026702, 33026704, 33036452, 33036453, 33045964, 33056440, 33119731, 33120913, 33167136 33169265, 33169266, 33169267

Distribution pattern

Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.

device · product 18 of 31

WALLFLEX PC ESOPH STENT 18/23MM X 123MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516910

Z-3282-2024
Recall number
Z-3282-2024
Initiated
August 01, 2024
Classification
Class II
Status
Ongoing
Quantity
308 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

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

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

Code information

GTIN: 08714729765257 Lot Numbers: 32780161, 32827704, 32875120, 32876612, 32915744, 32946076, 32967272, 32967273, 33014124, 33030431, 33045961, 33077152 33128873, 33146800, 33176330, 33195047, 33226266, 33233489, 33256090, 33256091

Distribution pattern

Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.

device · product 19 of 31

WALLFLEX PC ESOPH STENT 18/23MM X 153MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516920

Z-3283-2024
Recall number
Z-3283-2024
Initiated
August 01, 2024
Classification
Class II
Status
Ongoing
Quantity
39 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

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

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

Code information

GTIN: 08714729765264 Lot Numbers: 32965060, 33077153, 33120914, 33266650

Distribution pattern

Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.

device · product 20 of 31

WALLFLEX PC ESOPH STENT 23/28MM X 105MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516930

Z-3284-2024
Recall number
Z-3284-2024
Initiated
August 01, 2024
Classification
Class II
Status
Ongoing
Quantity
133 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

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

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

Code information

GTIN: 08714729765271 Lot Numbers: 32770265, 32799938, 32799939 32809371, 32809372, 32957301 33128874, 33156073, 33156074 33156075, 33156076, 33233491 33233492

Distribution pattern

Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.

device · product 21 of 31

WALLFLEX PC ESOPH STENT 23/28MM X 125MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516940

Z-3285-2024
Recall number
Z-3285-2024
Initiated
August 01, 2024
Classification
Class II
Status
Ongoing
Quantity
305 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

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Reason for recall

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

Code information

GTIN: 08714729765288 Lot Numbers: 32759900, 32759903, 32789717 32789718, 32829629, 32847692 32848481, 32898067, 32919347 32927195, 32949480, 32956257 32957302, 32965072, 32985475 32987961, 33047928, 33145976 33145978, 33208046, 33208048 33242626, 33275535

Distribution pattern

Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.

device · product 22 of 31

WALLFLEX PC ESOPH STENT 23/28MM X 155MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516950

Z-3286-2024
Recall number
Z-3286-2024
Initiated
August 01, 2024
Classification
Class II
Status
Ongoing
Quantity
199 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

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

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

Code information

GTIN: 08714729765295 Lot Numbers: 32764205, 32764206, 32827703 32837016, 32837017, 32850357 32869530, 32876613, 32891019 32900187, 32938379, 33145977 33160189, 33167134, 33242627

Distribution pattern

Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.

device · product 23 of 31

AGILE ESO OTW PC 23MM X 6.2CM IN 18.5 FR- Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas. Material Number (UPN): M00517710

Z-3287-2024
Recall number
Z-3287-2024
Initiated
August 01, 2024
Classification
Class II
Status
Ongoing
Quantity
6 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

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

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

Code information

GTIN: 00191506006587 Lot Numbers: 33178843

Distribution pattern

Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.

device · product 24 of 31

AGILE ESO OTW PC 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas. Material Number (UPN): M00517720

Z-3288-2024
Recall number
Z-3288-2024
Initiated
August 01, 2024
Classification
Class II
Status
Ongoing
Quantity
15 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

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

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

Code information

GTIN: 00191506006594 Lot Numbers: 33215327

Distribution pattern

Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.

device · product 25 of 31

AGILE ESO OTW PC 23MM X 12.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas. Material Number (UPN): M00517730

Z-3289-2024
Recall number
Z-3289-2024
Initiated
August 01, 2024
Classification
Class II
Status
Ongoing
Quantity
17 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

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

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

Code information

GTIN: 00191506006600 Lot Numbers: 33005086

Distribution pattern

Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.

device · product 26 of 31

AGILE ESO OTW PC 23MM X 15.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas. Material Number (UPN): M00517740

Z-3290-2024
Recall number
Z-3290-2024
Initiated
August 01, 2024
Classification
Class II
Status
Ongoing
Quantity
18 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

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

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

Code information

GTIN: 00191506006617 Lot Numbers: 33005084

Distribution pattern

Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.

device · product 27 of 31

AGILE ESO OTW FC 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas. Material Number (UPN): M00517760

Z-3291-2024
Recall number
Z-3291-2024
Initiated
August 01, 2024
Classification
Class II
Status
Ongoing
Quantity
18 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

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

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

Code information

GTIN: 00191506006631 Lot Numbers: 33005085

Distribution pattern

Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.

device · product 28 of 31

AGILE ESO OTW FC 23MM X 15.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas. Material Number (UPN): M00517780

Z-3292-2024
Recall number
Z-3292-2024
Initiated
August 01, 2024
Classification
Class II
Status
Ongoing
Quantity
19 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

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

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

Code information

GTIN: 00191506006655 Lot Numbers: 33266651

Distribution pattern

Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.

device · product 29 of 31

AGILE ESO FC RMV 23MM X 6.2CM IN 18.5 FR-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas. Material Number (UPN): M00517790

Z-3293-2024
Recall number
Z-3293-2024
Initiated
August 01, 2024
Classification
Class II
Status
Ongoing
Quantity
7 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

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

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

Code information

GTIN: 00191506006662 Lot Numbers: 32889020, 33178844

Distribution pattern

Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.

device · product 30 of 31

AGILE ESO FC RMV 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas. Material Number (UPN): M00517800

Z-3294-2024
Recall number
Z-3294-2024
Initiated
August 01, 2024
Classification
Class II
Status
Ongoing
Quantity
10 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

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

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

Code information

GTIN: 00191506006679 Lot Numbers: 33005087

Distribution pattern

Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.

device · product 31 of 31

AGILE ESO FC RMV 23MM X 15.0CM IN 18.5 F- Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas. Material Number (UPN): M00517820

Z-3295-2024
Recall number
Z-3295-2024
Initiated
August 01, 2024
Classification
Class II
Status
Ongoing
Quantity
6 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

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

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

Code information

GTIN: 00191506006693 Lot Numbers: 32889021, 33178845

Distribution pattern

Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.