Exact FDA event identifier

Event 68419

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

Event summary

Timeline bucket: May 28, 2014
Product types: Device
Classifications: Class I
Statuses: Terminated
Recalling firm wording: Nitinol Devices and Components, Inc.

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

12 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 12

HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Angled Tip, 150 CM Length Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.

Z-1812-2014

Recall number: Z-1812-2014
Initiated: May 28, 2014
Classification: Class I
Status: Terminated
Recalling firm: Nitinol Devices and Components, Inc.
Quantity: 8485 in US, 9595 - ROW - total, all models

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.

Code information

Model HPRA35150 - all lots.

Distribution pattern

Worldwide Distribution - USA (nationwide) and Internationally to Italy, France, Norway, Sweden, Germany, Belgium, United Kingdom and Canada.

device · product 2 of 12

HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Angled Tip, 180 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.

Z-1813-2014

Recall number: Z-1813-2014
Initiated: May 28, 2014
Classification: Class I
Status: Terminated
Recalling firm: Nitinol Devices and Components, Inc.
Quantity: 8485 in US, 9595 - ROW - total, all models

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.

Code information

Model HPRA35180 - all lots.

Distribution pattern

Worldwide Distribution - USA (nationwide) and Internationally to Italy, France, Norway, Sweden, Germany, Belgium, United Kingdom and Canada.

device · product 3 of 12

HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Angled Tip, 260 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.

Z-1814-2014

Recall number: Z-1814-2014
Initiated: May 28, 2014
Classification: Class I
Status: Terminated
Recalling firm: Nitinol Devices and Components, Inc.
Quantity: 8485 in US, 9595 - ROW - total, all models

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.

Code information

Model HPRA35260- all lots.

Distribution pattern

Worldwide Distribution - USA (nationwide) and Internationally to Italy, France, Norway, Sweden, Germany, Belgium, United Kingdom and Canada.

device · product 4 of 12

HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Straight Tip, 150 CM Length Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.

Z-1815-2014

Recall number: Z-1815-2014
Initiated: May 28, 2014
Classification: Class I
Status: Terminated
Recalling firm: Nitinol Devices and Components, Inc.
Quantity: 8485 in US, 9595 - ROW - total, all models

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.

Code information

Model HPRS35150- all lots.

Distribution pattern

Worldwide Distribution - USA (nationwide) and Internationally to Italy, France, Norway, Sweden, Germany, Belgium, United Kingdom and Canada.

device · product 5 of 12

HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile.Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Straight Tip, 180 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.

Z-1816-2014

Recall number: Z-1816-2014
Initiated: May 28, 2014
Classification: Class I
Status: Terminated
Recalling firm: Nitinol Devices and Components, Inc.
Quantity: 8485 in US, 9595 - ROW - total, all models

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.

Code information

Model HPRS35180- all lots.

Distribution pattern

Worldwide Distribution - USA (nationwide) and Internationally to Italy, France, Norway, Sweden, Germany, Belgium, United Kingdom and Canada.

device · product 6 of 12

HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Straight Tip, 260 CM Length Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.

Z-1817-2014

Recall number: Z-1817-2014
Initiated: May 28, 2014
Classification: Class I
Status: Terminated
Recalling firm: Nitinol Devices and Components, Inc.
Quantity: 8485 in US, 9595 - ROW - total, all models

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.

Code information

Model HPRS35260- all lots.

Distribution pattern

Worldwide Distribution - USA (nationwide) and Internationally to Italy, France, Norway, Sweden, Germany, Belgium, United Kingdom and Canada.

device · product 7 of 12

HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft, Angled Tip, 150 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA Manufactured in Costa Rica The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.

Z-1818-2014

Recall number: Z-1818-2014
Initiated: May 28, 2014
Classification: Class I
Status: Terminated
Recalling firm: Nitinol Devices and Components, Inc.
Quantity: 8485 in US, 9595 - ROW - total, all models

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.

Code information

Model HPSA35150- all lots.

Distribution pattern

Worldwide Distribution - USA (nationwide) and Internationally to Italy, France, Norway, Sweden, Germany, Belgium, United Kingdom and Canada.

device · product 8 of 12

HydroFinity Hydrophilic guidewire;Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft, Angled Tip, 180 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA Manufactured in Costa Rica. The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.

Z-1819-2014

Recall number: Z-1819-2014
Initiated: May 28, 2014
Classification: Class I
Status: Terminated
Recalling firm: Nitinol Devices and Components, Inc.
Quantity: 8485 in US, 9595 - ROW - total, all models

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.

Code information

Model HPSA35180- all lots.

Distribution pattern

Worldwide Distribution - USA (nationwide) and Internationally to Italy, France, Norway, Sweden, Germany, Belgium, United Kingdom and Canada.

device · product 9 of 12

HydroFinity Hydrophilic guidewire;Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft, Angled Tip, 260 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.

Z-1820-2014

Recall number: Z-1820-2014
Initiated: May 28, 2014
Classification: Class I
Status: Terminated
Recalling firm: Nitinol Devices and Components, Inc.
Quantity: 8485 in US, 9595 - ROW - total, all models

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.

Code information

Model HPSA35260- all lots.

Distribution pattern

Worldwide Distribution - USA (nationwide) and Internationally to Italy, France, Norway, Sweden, Germany, Belgium, United Kingdom and Canada.

device · product 10 of 12

HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft, Straight Tip, 150 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.

Z-1821-2014

Recall number: Z-1821-2014
Initiated: May 28, 2014
Classification: Class I
Status: Terminated
Recalling firm: Nitinol Devices and Components, Inc.
Quantity: 8485 in US, 9595 - ROW - total, all models

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.

Code information

Model HPSS35150- all lots.

Distribution pattern

Worldwide Distribution - USA (nationwide) and Internationally to Italy, France, Norway, Sweden, Germany, Belgium, United Kingdom and Canada.

device · product 11 of 12

HydroFinity Hydrophilic guidewire; 0.035 OD, Stiff Shaft, Straight Tip, 180 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.

Z-1822-2014

Recall number: Z-1822-2014
Initiated: May 28, 2014
Classification: Class I
Status: Terminated
Recalling firm: Nitinol Devices and Components, Inc.
Quantity: 8485 in US, 9595 - ROW - total, all models

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.

Code information

Model HPSS35180- all lots.

Distribution pattern

Worldwide Distribution - USA (nationwide) and Internationally to Italy, France, Norway, Sweden, Germany, Belgium, United Kingdom and Canada.

device · product 12 of 12

HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft, Straight Tip, 260 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA; Manufactured in Costa Rica The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.

Z-1823-2014

Recall number: Z-1823-2014
Initiated: May 28, 2014
Classification: Class I
Status: Terminated
Recalling firm: Nitinol Devices and Components, Inc.
Quantity: 8485 in US, 9595 - ROW - total, all models

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.

Code information

Model HPSS35260- all lots.

Distribution pattern

Worldwide Distribution - USA (nationwide) and Internationally to Italy, France, Norway, Sweden, Germany, Belgium, United Kingdom and Canada.